Medtronic 8831 SynchroMed Activator, Model 8831 User Manual manual

Medtronic, Inc. SynchroMed Activator, Model 8831 manual

manual

You and Your SynchroMed®ActivatorModel 8831 Activator for Your SynchroMed®or SynchroMed®EL Implantable Drug PumpPatient ManualCaution: Investigational Device. Limited by federal law (U.S.A.) to investigational use.Rx Only200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 1FCC ID: LF58831FCC ID: LF58831FCC ID: LF58831FCC ID: LF58831FCC ID: LF58831FCC ID: LF58831File No. NC1GXXXX01, Page AX of AXXFCC ID: LF58831
200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 2
A Company Dedicated to PatientsMedtronic was founded in 1949 by Earl Bakken, a graduate student inelectrical engineering, and his brother-in-law, Palmer J. Hermundslie.Today Medtronic is the world leader in medical technology, pioneeringtherapies that restore health, extend life and alleviate pain.From its modest beginnings in a 55-square-meter Minneapolis garage,we have transformed Medtronic into a worldwide company that servescustomers in more than 120 countries. Each year, millions of patientsare treated with Medtronic products and therapies. We invest almost$500 million each year in research and development, working closelywith the world’s leading physicians and scientists to enhance ourcurrent products and therapies, and to develop new ones. Although weare a large company, individual patients and their needs are still thedriving force behind what we do and how we do it.Our goal is to improve the quality of your life. This booklet, whichprovides information about your SynchroMed Activator, is one smallway we try to help.Welcome to the Medtronic family. We wish you well.200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 3
Explanation of SymbolsStatus Light SymbolsSuccessful Dose Activation Incomplete CommunicationInterval Lockout Activator Battery StatusMiscellaneous SymbolsIEC 60601-1, Type BF EquipmentAttention: See accompanying documentsCaution: This device contains a strong magnet. Proximity to recording tape and disksshould be avoided.Medtronic®, SynchroMed®, and SynchroMed®EL, are registered trademarks of Medtronic, Inc.Refer to the instructional label on the SynchroMed Activator for all applicable approvals.9Vwyw200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 4
CONTENTSFCC INFORMATION ........................................................ 1INTRODUCTION .............................................................. 2SYNCHROMED ACTIVATOR DESCRIPTION.......... 4SYNCHROMED ACTIVATOR COMPONENTS AND FEATURES ................................................................ 7Battery .............................................................................9Replacing the 9-Volt Battery .....................................10To remove the battery ..........................................13To install the battery.............................................14STORING YOUR ACTIVATOR IN ITS POUCH.......15ACTIVATION BUTTON..................................................18POSITIONING AND USINGYOUR SYNCHROMED ACTIVATOR..........................20How to use the SynchroMed Activator with your pump ....................................................21200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 5
INITIALIZATION .............................................................23UNDERSTANDING THE SYNCHROMED ACTIVATOR LIGHTS AND SOUNDS........................25TROUBLESHOOTING ....................................................29WHEN TO CALL YOURDOCTOR’S OFFICE .........................................................34Call your doctor’s office if .........................................34CLEANING AND CARE .................................................35SPECIFICATIONS.............................................................37Model 8831 SynchroMed ActivatorSpecifications ...............................................................37GLOSSARY.........................................................................38LIMITED WARRANTY....................................................41SERVICE..............................................................................45WARRANTY REGISTRATION CARD.........................47200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 6
FCC INFORMATIONThe following is communications regulation information on theModel 8831 SynchroMed®Activator.FCC ID: LF58831This device complies with Part 15 Rules. Operation is subject tothe following two conditions: (1) this device may not causeharmful interference and (2) this device must accept anyinterference received, including interference that may causeundesired operation.IMPORTANT: Changes or modifications to this product not authorizedby Medtronic, Inc., could void the FCC Certification and negate yourauthority to operate this product.1200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 1
INTRODUCTIONYou have been supplied with a Model 8831 SynchroMed®Activator that enables you to activate a programmed dose ofmedication prescribed by your doctor from your SynchroMed®or SynchroMed®EL Implantable Drug Pump.The SynchroMed Activator is one part of the system that wasprescribed for you and should be used only according to theinstructions given in this manual and those provided by yourdoctor.2200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 2
This manual will describe how to:• activate a dose of medication from your pump;• determine if an activation was successful; • determine if enough time has elapsed since your previousdose to allow you to activate another; and• understand the meaning of the lights on the back of yourSynchroMed Activator and of the audio signals from thedevice.If you have questions unanswered by this manual, or if anyunusual situations or problems arise, consult your doctor. He orshe knows your personal medical history and can give you thedetailed information you may need. In particular, you should askabout the potential complications, risks, and benefits of thistherapy.Important terms appear in bold text and are listed in the glossaryat the end of this manual. 3200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 3
SYNCHROMED®ACTIVATOR DESCRIPTIONThe SynchroMed Activator can “talk” and “listen” to yourSynchroMed pump. When you activate your device, it sends acommand to the pump to deliver a physician-programmed doseof medication. The SynchroMed Activator can also determine thetiming of your most recent dose. Additionally, the SynchroMedActivator “talks” to you. Through a series of lights and beeps, theSynchroMed Activator tells you if you are successful in yourattempt to activate the dose, if you are trying to activate a dosetoo soon since your last activation, and if the battery that powersyour SynchroMed Activator is good.Your doctor will program your pump to accept commands fromyour SynchroMed Activator. Your doctor will program thenumber of doses per 24 hours you may receive and the intervalbefore you may give yourself another dose, also known as theInterval Lockout.4200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 4
Be sure to talk with your doctor about the number of dosesprescribed for you and the interval lockout period between dosesso you understand how the SynchroMed Activator is intended towork. Your doctor may have to adjust your dose periodicallyuntil a dose schedule is found that is best for your needs.Use with Other Implanted Devices—The SynchroMed Activatorcan be used only with the SynchroMed family of pumps. TheSynchroMed Activator is not compatible with other program-mable pumps. The SynchroMed Activator may interfere with theoperation of other implantable devices. Tell your doctor if youhave another implanted device.7WarningRadio signals (telemetry) from the SynchroMed Activator may interferewith the performance of other implantable devices. Do not try to use theSynchroMed Activator to program another implantable device.5200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 5
Additionally, the SynchroMed Activator operates best in anenvironment free from strong electromagnetic interference (EMI).Examples of sources of EMI include, but are not limited to: strongcomputer monitors, television sets, and other electronicequipment.7CautionThe magnet in your SynchroMed Activator may interact with otherimplanted devices, impacting their operation or resetting their programs.If you have other implanted devices, talk with your doctor about themagnet in your SynchroMed Activator. Remember to keep yourSynchroMed Activator away from cards with magnetic strips (credit/bankcards) and from computer monitors and TVs.Refer to the SynchroMed pump patient manual for informationabout equipment and conditions that may affect the operation ofyour pump. If the SynchroMed Activator quits working, yoursymptoms may recur. 6200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 6
SYNCHROMED ACTIVATOR COMPONENTS AND FEATURESThis section describes the components and features of yourSynchroMed Activator.The Activation Button is located on the top of the SynchroMedActivator (Figure 1), as is the battery cover.Figure 1. SynchroMed Activator top view.7Finger GripsBattery CoverRelease TabActivationButtonBattery Cover200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 7
On the bottom of the SynchroMed Activator (Figure 2), you willsee four indicator lights and a “target” represented by a drawingof a hand holding a SynchroMed Activator.Figure 2. SynchroMed Activator bottom view.Medtronic Model 8831SynchroMed Activator9V®®8Successful Dose ActivationInterval LockoutIncomplete CommunicationSynchroMed ActivatorBattery StatusTarget Symbol200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 8
When you use your SynchroMed Activator, the four indicatorlights will help you understand how well the SynchroMedActivator is communicating with your pump. Each of the lightsrepresents a different message:• Successful dose activation•Interval lockout•Incomplete communication• SynchroMed Activator Battery statusRefer to page 25 for a detailed explanation of each message.BatteryYour SynchroMed Activator runs on one 9-volt battery. Youshould replace the battery in your SynchroMed Activator afterevery 12 weeks of typical use or when the battery light on theback of the SynchroMed Activator begins to blink or does notturn on.9200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 9
If the battery in your SynchroMed Activator is good, the greenbattery light on the back of the device will remain lit. If thebattery in your SynchroMed Activator begins to run low, thebattery indicator light on the back panel will begin to blink. The SynchroMed Activator performs a self test each time abattery is installed. You will see all of the lights on the back of theSynchroMed Activator turn on and you will hear a beep whenyou replace the batteries in your SynchroMed Activator.Replacing the 9-Volt BatteryReplace the battery in your SynchroMed Activator at least onceevery 12 weeks, or when the battery light on the back of theSynchroMed Activator begins to blink. 7WarningDo not use a mercury or zinc-air battery. Do not use rechargeable batteries.10200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 10
Dispose of depleted batteries according to local regulations.To remove the battery compartment cover (Figure 3):1. Hold the SynchroMed Activator with one hand.2. Press in the release button on the end of the SynchroMedActivator.3. Lift off the cover.Figure 3. Battery compartment cover removal.11200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 11
To replace the battery compartment cover:1. Place the center hook on the edge of the cover into thecenter slot on the SynchroMed Activator (Figure 4).2. Lower the battery compartment cover.3. Press down the end of the cover to lock it in place.Figure 4. Battery compartment cover replacement.12200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 12
To remove the battery:1. Remove the battery cover.2. Place one finger on the edge of the battery near the centerbottom.3. Lift the battery out of the compartment. To avoid damageto the SynchroMed Activator, do not use excessive force.Figure 5. Battery removal.Note: When not using the SynchroMed Activator for morethan 4 weeks, remove the battery to prevent corrosivedamage to the device.SN+13200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 13
To install the battery:1. Check the battery well for positive [+] and negative [-]contacts. Match them with the {+} and {-} symbols in thebattery compartment.2. Press the battery down fully into the battery compartmentwithout using excessive force.Figure 6. Battery installation.3. Replace cover.SN+1.2.14200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 14
157CautionDo not press the Activation Button during battery installation, because theSynchroMed Activator may “lock-up” and become non-functional. If youthink your SynchroMed Activator has locked up, remove the battery andinsert a fresh battery.STORING YOUR ACTIVATOR IN ITS POUCHWhen you are not using your Activator, store it in its pouch.Items such as bank or credit cards (with magnetic strips) andfloppy disks may be damaged by the magnet in your Activator.The pouch contains a hard metal shield that protects these typesof items from the magnet (Figure 7).200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 15
16Figure 7. Pouch with magnetic shield.ShieldUnderMesh200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 16
Place the Activator in the pouch so that the back of the Activator(the side with the lights) is against the side of the pouch thatcontains the shield (Figure 8).Figure 8. Storing your Activator in its pouch.17200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 17
ACTIVATION BUTTONWhen you place the SynchroMed Activator over the pump anddepress the Activation Button on your SynchroMed Activator, theSynchroMed Activator and the pump “talk“ to each other. A clock in the SynchroMed Activator keeps track of your intervallockout periods. You cannot activate more doses than your doctorprescribes in one 24-hour period.18200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 18
Figure 11. Activation button.When you depress the activation button on the SynchroMedActivator, you will receive one of several messages in the form oflights and audible signals (refer to page 25, “Understanding theSynchroMed Activator Lights and Sounds”).19Activation Button200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 19
POSITIONING AND USING YOUR SYNCHROMEDACTIVATORWhen you are ready to activate a dose, hold the SynchroMedActivator steadily over your drug pump for at least three secondsafter you have pressed the activation button. You must hold theSynchroMed Activator steadily to ensure that the SynchroMedActivator and the pump communicate.Note: If the SynchroMed Activator is not properlycentered over the pump after the activation button ispressed, successful communication between theSynchroMed Activator and the pump may not take place.20200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 20
21How to use the SynchroMed Activator with your pump:• Hold the SynchroMed Activator by the finger grips (Figure 1)on the sides of the device.• Use the target symbol on the back of the SynchroMedActivator to help you align the SynchroMed Activator overthe center of your pump (Figure 9).• Press the Activation Button and hold.• While the SynchroMed Activator is looking for the pump, youwill hear continuous beeping. After you find the pump andthe SynchroMed Activator communicates with it, the beepingwill stop. You may need to move the SynchroMed Activatorin a circular motion near your implanted pump in order foryour SynchroMed Activator to “find” your pump.Note: If you move the SynchroMed Activator away fromthe pump too soon, the beeping will start again. If thishappens, realign the SynchroMed Activator and try again.• When your SynchroMed Activator has successfullycommunicated with your pump, you will hear a sequence ofbeeps (refer to page 25, “Activator Lights and Sounds”).200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 21
22Figure 9. Correct placement of the SynchroMed Activator over a pump.200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 22
23INITIALIZATIONAfter you receive your SynchroMed Activator and each timeyour pump is reprogrammed or refilled, you must press theactivation button to begin the interval lockout. (Refer to page 18,“Positioning and Using Your SynchroMed Activator,” andfollow activation instructions).When the interval lockout period is over, you will be able toactivate a dose.Remember your SynchroMed Activator cannot activate a dosethe first time you use it. Instead, the device sets an intervallockout period the first time you activate after:• you first receive your SynchroMed Activator,• your pump is refilled, or• your doctor reprograms your pump.Activate your pump using your SynchroMed Activator as soonas possible after refill or programming to start the interval200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 23
lockout period the doctor has set. Ask your doctor how long thisperiod lasts for you. You can activate a dose as soon as theinterval lockout time ends, if needed.Figure 10 shows one example of a series of events from pumprefill to interval lockout end. Note that activation is permittedoutside the interval lockout period only.Figure 10. Graphic representation of activation and interval lockout period.Refill or Reprogram Pump IntervalLockoutPeriodIntervalLockoutPeriodTime (hours)Interval LockoutPeriod Expires PatientActivationInitializeActivator Lockout12345678910111213141516171824200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 24
UNDERSTANDING THE SYNCHROMED ACTIVATORLIGHTS AND SOUNDSThis section explains the light and sound messages yourSynchroMed Activator sends you. Refer to Figure 2 as you readthe text below.On the row of lights on the back of your SynchroMed Activator,the top light (SUCCESS) turns green immediately after yousuccessfully activate a dose.If you try to activate a dose too soon after your last activation, ayellow light (second from the top) will turn on (INTERVALLOCKOUT).If you try to activate a dose, and communication is notestablished with your pump, the third light in the row will turnon yellow (INCOMPLETE COMMUNICATION). 25200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 25
26The green light at the bottom of the row (BATTERY STATUS) willremain green during activation as long as the 9-volt battery inyour SynchroMed Activator is good. When the battery is low, thelight will begin to blink green. (The light will not turn on at all ifthe battery is too low to operate the SynchroMed Activator.) All lights remain on for 8 seconds.Your SynchroMed Activator produces different series of beeps forvarious messages:• Three beeps (ascending tones) in rapid succession mean adose activation was successful.• Two beeps (ascending tones) in rapid succession mean yourSynchroMed Activator was initialized following aprogramming session with your doctor. • Two beeps (descending tones) in rapid succession mean oneof the following:– You tried to activate a dose too soon following your mostrecent activation.200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 26
27– You tried to activate too many doses within a 24-hourperiod (more than prescribed by your doctor).– Your SynchroMed Activator did not communicatecompletely with your pump within 10 seconds.– Your pump has not been programmed for SynchroMedActivator useThe beeper cannot be turned off, and the volume is notadjustable.Note: If you hear two beeps (descending tones), but youbelieve that your interval lockout period is over, try oncemore to activate a dose. If you are still unsuccessful, checkyour records to determine the number of doses activatedin the past 24 hours (refer to pages 39-40).200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 27
28Table 1. SynchroMed Activator Lights and SoundsSynchroMed Activator SynchroMed Activator SynchroMed ActivatorIndicator Light Light Color SoundsSuccessful dose activation Green light 3 beeps (ascending tones)Interval lockout Yellow light 2 beeps (descending tones)Incomplete communication Yellow light 2 beeps (descending tones)SynchroMed Activator Green light=good Nonebattery status Green light blinking=replace batteryInitialization Yellow light 2 beeps (ascending tones)200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 28
29TROUBLESHOOTINGThe following table presents potential difficulties that mightoccur when you are trying to use your SynchroMed Activator,and possible solutions for those difficulties.Table 2. TroubleshootingIf this happens This might be why Try these stepsNo lights appear • Sunlight may be obscuring • Shade the lights or to be functioning the view move into a darker area• No battery • Replace the battery• Very low battery • Check to see that the• Battery placement incorrect battery is inserted correctlyThe beeper does • You may not be able to hear • Move to a quieter areanot sound, but the the beeper because of noise battery light is on around you• The beeper may be broken • Call your doctor200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 29
30If this happens This might be why Try these stepsThe SynchroMed • Button may be broken • Check to see that theActivator does not • No battery battery is inserted correctlyrespond to button • Very low battery • Replace the batterypresses• • Call your physician if youyou have checked and replaced the battery, butyour Activator is still not responding200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 30
If this happens This might be why Try these stepsSynchroMed Activator • SynchroMed Activator • Realign the SynchroMedindicates that communi- is not close enough Activator using the target cation with pump (within 5 cm) to the pump on the devicewas incomplete; • The SynchroMed Activator • Ensure that the Synchro-(incomplete light is yellow is not aligned properly Med Activator is in and two descending with the pump contact with the skin ortones sound) • The SynchroMed Activator clothing directly over was moved too quickly the pump; if necessary, away from the pump ask someone to help you• Excessive EMI (proximity to • Position the SynchroMed strong computer monitors or Activator over the pumpother electronic equipment) at least 3 seconds after you push the activationbutton. Do not move theSynchroMed Activatorquickly away from the pump location• Move away from possibleEMI sources such as TV’s or large computermonitors31200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 31
If this happens This might be why Try these stepsAfter communication • The pump has a • Call your doctor with the pump, the memory error immediatelySynchroMed Activator continually beeps and all lights flashAll lights are on, but the • Self-test has failed • Remove battery and device is non-functional insert new battery• Contact your physician32200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 32
33Following are some guidelines for using your SynchroMedActivator.Do:• Use your SynchroMed Activator only as your doctor hasexplained to you.• Handle your SynchroMed Activator with care. Do not drop,throw, or toss your SynchroMed Activator, or immerse it inwater or any other liquid.• Keep a fresh 9-volt battery on hand so that you can replacethe SynchroMed Activator battery when needed.200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 33
WHEN TO CALL YOUR DOCTOR’S OFFICECall your doctor’s office if:• you experience anything unusual, such as new orunexplained symptoms;• you notice that you begin to feel differently or worse;• your symptoms do not decrease with activation of a dose;• you are not getting adequate relief from your symptoms;• your symptoms have dramatically changed; or• your SynchroMed Activator beeps continually followingcommunication with the pump, and all lights flash.34200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 34
CLEANING AND CAREThe SynchroMed Activator is a precision instrument and shouldbe handled with care.Disassembling or tampering with the internal components of theSynchroMed Activator could damage it and make it inoperable.Although the SynchroMed Activator construction is rugged, itshould be protected against sharp blows or physical shocks. Donot drop or toss your SynchroMed Activator.Clean the outside of the SynchroMed Activator with a slightlydamp cloth. Mild household cleaners will not damage the case orlabels. Your SynchroMed Activator is water resistant, notwaterproof. Do not immerse the SynchroMed Activator in wateror any other liquid.Be careful to prevent moisture from entering the SynchroMedActivator. 35200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 35
7CautionDo not immerse the SynchroMed Activator in liquid, or clean it witharomatic or chlorinated hydrocarbons, or acetone (for example, bleach ornail polish remover).If the battery contacts require cleaning, clean them with a cottonswab dampened with rubbing alcohol. Do not use a pencileraser or sandpaper.Replace a depleted battery to ensure proper operation and toprevent corrosion.36200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 36
SPECIFICATIONSModel 8831 SynchroMed Activator SpecificationsPower Source: 9-volt alkaline (type 6LR61 or 6F22E) batteryOperating Temperature: 49˚F—110˚F (9˚ C—43˚C)Storage Temperature: -40˚F—150˚F (-40˚C—65˚C )Relative Humidity: 10—95%SynchroMed Activator Size: Approximately 5.3x2.4x1.2 inches (13.5x6.1x3.0 cm)SynchroMed Activator Weight: Approximately 7 oz (198g)(including battery)Battery Life: 12 weeks (average)37200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 37
38GLOSSARYDose Activation—The initiation of a command from yourSynchroMed Activator to your SynchroMed pump that tells thepump to activate a prescribed dose of medication.Incomplete Communication—The failure of your SynchroMedActivator to complete delivery of a message to your pump.Interference—Anything that reduces the effectiveness orinterferes with the communication between your SynchroMedActivator and pump.Interval Lockout—A period of time during which you cannotactivate a dose using your SynchroMed Activator. This timeperiod is determined by your physician.200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 38
Retain the following information for your records and foryour doctor.Date of Activation Time of Activations____________ ________________________ ________________________ ________________________ ________________________ ________________________ ________________________ ________________________ ____________39200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 39
Date of Activation Time of Activations____________ ________________________ ________________________ ________________________ ________________________ ________________________ ________________________ ________________________ ________________________ ________________________ ____________40200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 40
MEDTRONIC®NEUROLOGICAL EQUIPMENTLIMITED WARRANTY(U.S. Customers Only)A. This Limited Warranty provides the following assurance to the purchaser of the Medtronic®Model 8831 SynchroMed®Activator hereafter referred to as “Equipment“:(1) Should the Equipment fail to function within normaltolerances due to a defect in materials or workmanshipwithin a period of one (1) year, commencing with thedelivery of the Equipment to the purchaser, Medtronic willat its option: (a) repair or replace any part or parts of theEquipment; (b) issue a credit to the purchaser equal to thePurchase Price, as defined in Subsection A(2), against thepurchase of the replacement Equipment or (c) provide afunctionally comparable replacement Equipment at nocharge.41200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 41
42(2) As used herein, Purchase Price shall mean the lesser of thenet invoiced price of the original, or current functionallycomparable, or replacement Equipment.B. To qualify for Limited Warranty set forth in Section A(1), thefollowing conditions must be met:(1) The Equipment must be returned to Medtronic withinthirty (30) days after discovery of the defect (Medtronicmay, at its option, repair the Equipment on site).(2) The Equipment must not have been repaired or alteredoutside of Medtronic's factory in any way which, in thejudgment of Medtronic, affects its stability and reliability.The Equipment must not have been subjected to misuse,abuse, or accident.200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 42
43C. This Limited Warranty is limited to its express terms. Inparticular:(1) Except as expressly provided by this Limited Warranty,MEDTRONIC IS NOT RESPONSIBLE FOR ANY DIRECT,INCIDENTAL OR CONSEQUENTIAL DAMAGES BASEDON ANY DEFECT, FAILURE, OR MALFUNCTION OFTHE EQUIPMENT, WHETHER THE CLAIM IS BASEDON WARRANTY, CONTRACT, TORT, OR OTHERWISE.(2) This Limited Warranty is made only to the purchaser of theEquipment. AS TO ALL OTHERS, MEDTRONIC MAKESNO WARRANTY, EXPRESS OR IMPLIED, INCLUDING,BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OFMERCHANTABILITY OR FITNESS FOR A PARTICULARPURPOSE WHETHER ARISING FROM STATUTE,COMMON LAW, CUSTOM, OR OTHERWISE. NOEXPRESS OR IMPLIED WARRANTY TO THE PATIENTSHALL EXTEND BEYOND THE PERIOD SPECIFIED INA(1) ABOVE. THIS LIMITED WARRANTY SHALL BETHE EXCLUSIVE REMEDY AVAILABLE TO ANYPERSON.200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 43
(3) The exclusions and limitations set out above are notintended to, and should not be construed so as tocontravene mandatory provisions of applicable law. If anypart or term of this Limited Warranty is held to be illegal,unenforceable, or in conflict with applicable law by a courtof competent jurisdiction, the validity of the remainingportions of the Limited Warranty shall not be affected, andall rights and obligations shall be construed and enforcedas if this Limited Warranty did not contain the particularpart or term held to be invalid. This Limited Warrantygives the purchaser specific legal rights. The purchasermay also have other rights which vary from state to state.(4) No person has any authority to bind Medtronic to anyrepresentation, condition, or warranty except this LimitedWarranty.* This Limited Warranty is provided by Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604. It applies only in the United States. Areas outside the United States should contact their local Medtronicrepresentative for exact terms of the Limited Warranty.44200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 44
45SERVICEThe SynchroMed Activator has been carefully engineered andtested to provide long, trouble-free service. If repair or service isnecessary, call Medtronic at 1-800-328-0810.To register the activator for service covered by the limitedwarranty, complete and mail the warranty registration cardinserted in this manual. A serial number, located within the battery compartmentidentifies each activator. If you write or call Medtronic aboutyour activator, refer to the serial number.200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 45
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NO POSTAGENECESSARYIF MAILEDIN THEUNITED STATESBUSINESS REPLY MAILFIRST-CLASS MAIL PERMIT NO. 7611 MINNEAPOLIS, MNPOSTAGE WILL BE PAID BY ADDRESSEEMEDTRONIC NEUROLOGICALDEVICE REGISTRATION MS LN385PO BOX 59262MINNEAPOLIS MN 55459-9895200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 47
IMPORTANT: Please detach, fill out, and mail this card to register your activator.(The serial number is located under the 9-volt battery.)SynchroMed® Activator Model 8831 Warranty Registration CardPurchase Date:(Mo)(Last) (First)(Area Code)(Day) (Yr)Name:(Last) (First)Name:Address:City:Zip Code:Zip Code:Implant Physician Name:Hospital Name:State:Address:City: State:Phone: () -Phone: () --Serial Number: NGM-200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 48
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Medtronic, Inc.710 Medtronic Parkway NE Minneapolis, MN 55432-5604USAInternet: www.medtronic.comTel. 763-505-5000Toll-free 1-800-328-0810Fax 763-505-1000UC200102537 ENPN198565-001© Medtronic, Inc. 2001All Rights Reserved200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 50

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